0 Ratings
ID

42098

Description

Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02109653

Link

https://clinicaltrials.gov/show/NCT02109653

Keywords

Versions (2)
  1. 9/28/15 9/28/15 - Julian Varghese
  2. 4/9/21 4/9/21 - Ahmed Rafee, MD
Copyright Holder

AR

Uploaded on

April 9, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Non-Small Cell Lung Cancer NCT02109653

    English

    Eligibility Non-Small Cell Lung Cancer NCT02109653

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    presence of braf v600e mutation in tumor tissue
    Description

    v600e mutation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3811884
    histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc
    Description

    stage iiib or iv nsclc

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0278984
    UMLS CUI [2]
    C0278987
    at least one measurable lesion as defined by recist v1.1
    Description

    measurable lesion as defined by recist

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1513040
    UMLS CUI [1,3]
    C1709926
    patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic nsclc.
    Description

    systemic, anti-cancer treatment; advanced or metastatic nsclc

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1515119
    UMLS CUI [1,2]
    C0920425
    eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2
    Description

    eastern cooperative oncology group; performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with symptomatic central nervous system (cns) metastases
    Description

    symptomatic central nervous system involvement; metastases; cns

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0686377
    UMLS CUI [1,2]
    C0231220
    history of leptomeningeal metastases
    Description

    leptomeningeal metastases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1704231
    prior therapy with a braf inhibitor
    Description

    prior therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3838813
    patients taking prohibited medication listed in the protocol
    Description

    medication; protocol

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
    Description

    malignant disease other than nsclc

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    impaired cardiovascular function or clinically significant cardiovascular diseases
    Description

    significant cardiovascular diseases

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0205082
    pregnant or lactating women or woman of childbearing potential
    Description

    pregnant or lactating women of childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    UMLS CUI [2]
    C2828358
    UMLS CUI [3]
    C3831118
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    Similar models

    Eligibility Non-Small Cell Lung Cancer NCT02109653

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    v600e mutation
    Item
    presence of braf v600e mutation in tumor tissue
    boolean
    C3811884 (UMLS CUI [1])
    stage iiib or iv nsclc
    Item
    histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc
    boolean
    C0278984 (UMLS CUI [1])
    C0278987 (UMLS CUI [2])
    measurable lesion as defined by recist
    Item
    at least one measurable lesion as defined by recist v1.1
    boolean
    C0221198 (UMLS CUI [1,1])
    C1513040 (UMLS CUI [1,2])
    C1709926 (UMLS CUI [1,3])
    systemic, anti-cancer treatment; advanced or metastatic nsclc
    Item
    patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic nsclc.
    boolean
    C1515119 (UMLS CUI [1,1])
    C0920425 (UMLS CUI [1,2])
    eastern cooperative oncology group; performance status
    Item
    eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    symptomatic central nervous system involvement; metastases; cns
    Item
    patients with symptomatic central nervous system (cns) metastases
    boolean
    C0686377 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    leptomeningeal metastases
    Item
    history of leptomeningeal metastases
    boolean
    C1704231 (UMLS CUI [1])
    prior therapy
    Item
    prior therapy with a braf inhibitor
    boolean
    C3838813 (UMLS CUI [1])
    medication; protocol
    Item
    patients taking prohibited medication listed in the protocol
    boolean
    C0525058 (UMLS CUI [1])
    malignant disease other than nsclc
    Item
    presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
    boolean
    C0006826 (UMLS CUI [1])
    significant cardiovascular diseases
    Item
    impaired cardiovascular function or clinically significant cardiovascular diseases
    boolean
    C0007222 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    pregnant or lactating women of childbearing potential
    Item
    pregnant or lactating women or woman of childbearing potential
    boolean
    C0549206 (UMLS CUI [1])
    C2828358 (UMLS CUI [2])
    C3831118 (UMLS CUI [3])
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